Director of Quality

Director of Quality

Requirements

• Bachelor’s degree in Engineering, Biology, Chemistry, Biochemistry or other relevant Life Science discipline with twelve (12) years’ experience supervising staff in a Quality Operations role and/or cGMP environment; OR
• Master’s degree in Engineering, Biology, Chemistry, Biochemistry or other relevant Life Science discipline with ten (10) years’ experience supervising staff in a Quality Operations role and/or cGMP environment; OR
• PhD in Engineering, Biology, Chemistry, Biochemistry or other relevant Life Science discipline with seven (7) years’ experience supervising staff in a Quality Operations role and/or cGMP environment
• Experience supervising staff in a Quality Control and/or cGMP environment
• Familiarity with disciplines outside of primary areas of expertise

Responsibilities

• Reports to the Executive Director of Quality and provides direction to Associate Directors, Managers, and professional staff.
• Contributes to departmental performance by adapting plans and priorities to meet operational challenges and aligning staff activities with objectives.
• Offers technical support and interprets client needs to identify effective solutions.
• Demonstrates strong written and verbal communication abilities, including preparing and delivering presentations to external stakeholders.
• Works independently and collaboratively within teams, fostering effective relationships across departments.
• Plans and oversees departmental activities to achieve objectives.
• Manages performance and career development for supervisory and technical staff.
• Develops and implements operational policies and procedures.
• Reviews and approves lot disposition recommendations and deviation investigations.
• Administers budgets, schedules, and performance metrics, ensuring accountability for results.
• Participates in decision-making for capital expenditures and new technology acquisitions, while developing staffing plans and justifications.
• Utilizes continuous improvement methodologies to enhance departmental efficiency and maintain high-quality standards.
• Represents the department during FDA and other regulatory inspections, ensuring compliance and defending quality data.
• Identifies and resolves technical and operational issues, collaborating with peers across interrelated units.
• Recognizes that errors may lead to GMP compliance issues, regulatory deficiencies, and project delays, necessitating resource allocation for corrections.
• Makes informed decisions guided by policies and procedures, consulting with management on complex issues impacting interrelated processes.
• Adapts departmental plans based on operational challenges and division scorecards.
• Forecasts resource needs and manages the allocated budget effectively.
• Accountable for the performance of a small manufacturing sub-segment with plant transfers to inventory under $25M, typically managing Associate Directors and Managers.
• Ability to sit, stand, and move within the workspace for extended periods, and perform repetitive tasks involving hand manipulations.
• Engages with employees at all levels, interacts with FDA inspectors and regulatory agencies, and collaborates with vendors, contractors, suppliers, and partners.

Preferred Qualifications

No preferred qualifications provided.